Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

Kodak's CEO Leans Into Biopharma Manufacturing – "I'm An Operator"

Kodak’s Eastman Business Park in Rochester was the focus of a recent editorial. But the man leading Kodak’s comeback, Jim Continenza, Chairman and CEO, is a topic unto himself. He’s as animated as any public-company CEO you’ll encounter. And he knows his audience; in his conversation with Chief Editor Louis Garguilo he says Kodak “has always supplied CDMOs and the industry with important chemicals.” Read his vigorous take on domestic manufacturing and other supply-chain topics.

GUEST COLUMNISTS

Why Isolators Do Not Automatically Ensure Annex 1 Compliance
Isolators are powerful tools, but they do not automatically ensure compliance with EU GMP Annex 1. RABS are frequently dismissed too quickly. The difference is not the technology itself, but how it is applied.
Why Are Life Science Companies So Poorly Prepared For RIM's Future?
Most organizations have modernized their global regulatory information management (RIM) systems and improved data quality. Yet modernization and readiness are not the same thing.
CDMO Capacity Crunch: Are Biotechs Wasting Time On The Wrong CDMO?
Biotechs often default to one of two flawed instincts: pursue the biggest name in the space or go with the lowest bidder. To avoid misalignment, look at these less visible factors.
April 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
Tackling The Cell & Gene Therapy Sector's Practical Post-Approval Problem
As the regulatory landscape continues to evolve, cell and gene therapy companies must plan post-approval change programs with regulatory monitoring built in from the start.
Why Your MES RFP Is Failing Before It Starts
Many manufacturing execution system requests for proposals fail. Not because vendors cannot deliver or the tech is immature, but because the requirements are written backward.
Here's How FDA's Accelerated Approval Pathway Has Evolved Since '24
FDA's accelerated approval guidance kicked off a rebalancing of new drug approval pathways. Since its 2024 release, the agency has been building on it in a few key areas.
Gaining An Edge In GLP-1 Production
The shortage-driven production of GLP-1 drugs of the past few years is giving way to a long-term operation model characterized by digital enablement and supply chain resilience.

PHARMA OUTSOURCING WHITE PAPERS

De-Risk Nucleic Acid Therapeutics Through Strategic Outsourcing
Bringing a nucleic acid therapy to market requires specialized formulation and development knowledge. Innovators need rigorous analytical and formulation strategies to achieve stability and quality.

A New Framework For Identifying Nitrosamine Risks And Derisking Products
Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.
Practical Considerations For Your Process Characterization Study
Outsourced process characterization can save time, but only with the right preparation. Clear expectations around materials and data interpretation help reduce rework and strengthen confidence.
A Cell Line Development Platform Accelerating Timelines To Clinic
To support a seamless transition from early clinical studies through to commercial manufacturing, cell line expression systems must be carefully designed and selected based on several critical attributes.
Effect of Shelf Cooling Rate on the Nucleation Temperature of Ice Monitored Using Thermocouples and Wireless Temperature Sensors
Freezing conditions shape ice structure, mass transfer resistance, and drying efficiency. Data shows how cooling rate, vial size, and nucleation interact to optimize freeze-drying.
Advanced Methodology Of PLGA-Based Parenteral Formulations
To enable the development of optimized PLGA-based sustained release formulations, this paper offers essential insights into the polymer’s properties, fabrication techniques, and drug release mechanisms.